(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulty appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a lesion located in the diagonal of the left anterior descending artery at the bifurcation.During post-dilatation, when advancing a 3.0 x 12 mm nc trek through a guiding catheter, the proximal shaft suddenly broke and separated into two pieces outside the anatomy.There was no resistance noted between the guiding catheter and the balloon catheter, and no other reported issues.The procedure was successfully completed with a 2.75 x 12 mm nc trek.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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